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NBI-98854 once daily

Phase 1

Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects | Small molecule | Other |Neurocrine Biosciences, Inc.|Last Updated: Sep 5, 2013

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

NBI-98854 once daily · 1 trial · 1 indication

Phase 1 1
NCT01910480Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy SubjectsEffect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
COMPLETED24 Analytics
PHASE1COMPLETED
Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
NCT0191048024
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Study Endpoints

Primary Endpoints

Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 alone
45 minutes prior to NBI-98854 dosing, and at 15, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 48, 72 and 96 hours postdose
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 concomitantly with ketoconazole
at 45 minutes prior to NBI-98854 dosing, and at 15, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 48, 72 and 96 hours postdose
Number of Participants with Adverse Events following dosing with NBI-98854
Up to 31 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
NBI-98854 followed by NBI-98854 with ketoconazoleEXPERIMENTAL50 mg NBI-98854 on Study Days 1 and 6 and 200 mg ketoconazole twice daily on Study Days 5 through 9.

Interventions

NameTypeDescription
NBI-98854 50 mg capsule once dailyDRUG -
Ketoconazole 400 mg (200 mg twice daily)DRUG -
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female volunteer, 18 to 40 years of age. * Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. * Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeedi...

Countries:United States
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Frequently asked questions about NBI-98854 once daily

What is NBI-98854 once daily used for?

NBI-98854 once daily is an investigational small molecule being studied for its pharmacokinetics in healthy subjects, specifically to assess the effect of ketoconazole on its metabolism. It is in Phase 1 clinical development and is not approved for any indication.

Who makes NBI-98854 once daily?

NBI-98854 once daily is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting clinical trials to evaluate the drug's pharmacokinetic profile in healthy volunteers.

What phase is NBI-98854 once daily in?

NBI-98854 once daily is in Phase 1 clinical development. A Phase 1 study assessing the effect of ketoconazole on the pharmacokinetics of NBI-98854 in healthy subjects has been completed. The drug remains investigational and has not received FDA approval.

What clinical trials is NBI-98854 once daily in?

NBI-98854 once daily has one completed clinical trial, NCT01910480, titled "Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects." This Phase 1 study enrolled 24 healthy volunteers in the United States and was not randomized or blinded.

Is NBI-98854 once daily FDA approved?

NBI-98854 once daily is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on pharmacokinetics in healthy subjects, and the drug has not yet progressed to later-stage trials or regulatory submission.